This is an open-label pilot trial to assess the safety and feasibility of a novel 8-week psilocybin-assisted psychotherapy intervention to facilitate successful tapering/discontinuation of opioid pain medication in adult patients receiving long-term opioid therapy for chronic pain. Participation will last approximately 8 months and includes one or two psilocybin-assisted therapy sessions. The study will evaluate the incidence and severity of adverse events during and after treatment, the number of participants who drop out of the study for intervention-related reasons, and the self-reported benefits and harms of the intervention.
The purpose of this pilot study is to establish the safety and tolerability of a therapeutic intervention using psilocybin-assisted psychotherapy as a novel treatment for opioid tapering in a sample of patients with chronic pain. Participants will be patients who have failed previous attempts to reduce their use of opioid medication and who have no medical or psychological contraindications for psilocybin administration. This pilot study involves an 8-week open-label, non-randomized therapeutic intervention and a 6-month follow-up period. To provide a supportive context for the drug experience, participants will receive preparatory and integrative sessions following an acceptance and commitment therapy model for psychedelic therapy. The physician-supervised opioid taper will begin following the first psilocybin dosing session (25mg) after an integration session with therapists, and a second optional psilocybin dosing session (37.5mg) will be facilitated one month later. Assessments will be completed at baseline, and at follow-up points at 1-month, 3-months and 6-months post-intervention to evaluate both acute and long-term effects of the intervention. Primary outcomes of interest are rates of adverse events, retention rates, and patient perceptions of intervention tolerability. Preliminary efficacy of the treatment will be evaluated by tracking opioid reduction rates and long-term maintenance of these reductions. Other measures of interest include qualities of the psychedelic experience, opioid cravings and withdrawal, chronic pain symptoms, and psychological mechanisms.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Participants will complete a 8-week structured psychotherapeutic intervention involving administration of 25mg and 37.5mg PEX010 on two separate occasions.
University of British Columbia - Okanagan Campus
Kelowna, British Columbia, Canada
RECRUITINGFeasibility of psilocybin administration
Percentage of participants who provide consent and complete the intervention.
Time frame: Week 31
Acceptability of psilocybin administration
Participant ratings of benefits and harms of the intervention.
Time frame: Week 31
Safety of psilocybin administration
Number and type of treatment-related adverse events and serious adverse events reported during the intervention.
Time frame: Up to 33 Weeks
Change in prescribed opioid dose at the 1-month visit compared to initial dose
Taper adherence rates will be assessed by categorizing participants as "adhering", or "non-adhering" based on percentage of the initial dose that they are using at the 1-month timepoint.
Time frame: Week 11
Change in prescribed opioid dose at the 3-month visit compared to initial dose
Taper adherence rates will be assessed by categorizing participants as "adhering", or "non-adhering" based on percentage of the initial dose that they are using at the 3-month timepoint.
Time frame: Week 19
Change in prescribed opioid dose at the 6-month visit compared to initial dose
At 6-month follow-up participants will be categorized as "successful" if they have discontinued opioid therapy, and "unsuccessful" if they have not.
Time frame: Week 31
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